Isa™ Or+

FDA UDI

Class II (US FDA UDI)

by Masimo Corporation

Identity

Trade Name: ISA™ OR+ FDA UDI
Generic Name: Patient monitoring system module, multiple-gas FDA UDI
Model / Reference: OR+ FDA UDI

Identifiers

Primary DI / UDI-DI: 07350046131811 FDA UDI
FDA Product Code: CCL FDA UDI
NHQ FDA UDI
NHP FDA UDI
NHO FDA UDI
CBS FDA UDI
CBR FDA UDI
CBQ FDA UDI
CCK FDA UDI
GMDN Term: Patient monitoring system module, multiple-gas FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 868.1720 FDA UDI
868.1500 FDA UDI
868.1620 FDA UDI
868.1700 FDA UDI
868.1400 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Patient monitoring system module, multiple-gas

Isa™ Or+ by Masimo Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Masimo Corporation

Sources (1)

FDA UDI 0be313c9-dbaf-4520-846d-a6d63fcf38bc 32 fields · synced May 30, 2026